PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Report

• Report Number: 1020279-2025-01716
• Event Type: Injury
• Date Received: October 15, 2025
• Report Date: October 28, 2025
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: MEH
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: REFLECTION ACETABULAR SHELL COMPONENTS: IMPLANTED IN FIFTEEN THOUSAND FOUR HUNDRED AND FIFTY-SIX (15,456) HIPS BETWEEN 02-SEP-1999 AND 28-JAN-2025. THIS TOTAL INCLUDES CUPS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES MBL AND MEH. OF THE EIGHT HUNDRED FORTY-TWO (842) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FOUR HUNDRED SEVENTY-FIVE (465) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 842 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MEH. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, NINE (9) HIPS DUE TO PAIN, SEVEN (7) HIPS DUE TO INSTABILITY, SIX (6) HIPS DUE TO LEG LENGTH DISCREPANCY, SIX (6) HIPS DUE TO MALPOSITION, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, FOUR (4) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, ONE (1) HIP DUE TO WEAR ¿ ACETABULUM AND FOUR (4) HIPS DUE TO OTHER-UNSPECIFIED REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 842 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 465 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 465 CASES. REDAPT SLEEVELESS REVISION STEMS: IMPLANTED IN ONE HUNDRED AND THIRTY-ONE (131) HIPS BETWEEN 22-JUL-2018 AND 8-APR-2025.FROM THESE, EIGHT (8) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: FIVE (5) HIPS DUE TO INFECTION, ONE (1) HIP DUE TO PROSTHESIS DISLOCATION, ONE (1) HIP DUE TO FRACTURE, AND ONE (1) HIP DUE TO MALPOSITION. BASED ON THE LEVEL OF DATA STRATIFICATION PROVIDED BY THE AOANJRR REGISTRY, THE REPORTED REASONS FOR REVISION CANNOT BE CONCLUSIVELY LINKED TO THE STEM MODEL NUMBERS LISTED IN EACH SPECIFIC LINE ITEM OF THE .CSV FILE ATTACHED TO THE SUMMARIZED 3500A SUBMISSION UNDER EXEMPTION RWD2300584, DUE TO THE REGISTRY¿S LIMITATION IN CORRELATING CLINICAL SYMPTOMS WITH INDIVIDUAL IMPLANT COMPONENTS. 2. REVISION THA PROCEDURES: REFLECTION HA THREE-HOLE ACETABULAR SHELL COMPONENTS: IMPLANTED IN NINETY-FIVE (95) HIPS BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES CUPS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES MEH, LPH, MBL. OF THE EIGHTEEN (18) RE-REVISION SURGERIES REPORTED FOR THESE IMPLANTS, TEN (10) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION HA THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MEH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR RE-REVISION FOR ALL 18 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MEH. THE REPORTED REASONS FOR REVISION INCLUDE: SIX (6) HIPS DUE TO PROTHESIS DISLOCATION, FIVE (5) DUE TO INFECTION, AND THE SEVEN (7) REMAINING JOINTS BECAUSE OF THE FOLLOWING CAUSES (ONE PER JOINT): LOOSENING, FRACTURE, STEM IMPLANT BREAKAGE, LYSIS, PAIN, HETEROTOPIC BONE, AND WEAR OF THE ACETABULAR INSERT. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 18 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 10 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION HA THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MEH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 10 CASES. REFLECTION 3-HOLE ACETABULAR SHELL COMPONENTS: IMPLANTED IN SIXTY-EIGHT (68) HIPS BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES CUPS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES MBL AND MEH. OF THE FIFTEEN (15) RE-REVISION SURGERIES REPORTED FOR THESE IMPLANTS, TEN (10) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION 3-HOLE ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF RE-REASONS FOR ALL FIFTEEN (15) RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MEH. THE REPORTED REASONS FOR RE-REVISION INCLUDE: SIX (6) HIPS DUE TO LOOSENING, SEVEN (7) HIPS DUE TO PROSTHETIC DISLOCATION AND TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL FIFTEEN (15) RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 10 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION 3-HOLE ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 10 CASES. REDAPT SLEEVELESS REVISION STEMS: IMPLANTED IN THREE HUNDRED AND FORTY-FIVE (345) HIPS BETWEEN 24-AUG-2018 AND 31-MAY-2025. FROM THESE, TWENTY-FIVE (25) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TEN (10) HIPS DUE TO INFECTION, FIVE (5) HIPS DUE TO LOOSENING, FOUR (4) HIPS DUE TO PROSTHESIS DISLOCATION, FOUR (4) HIPS DUE TO FRACTURE, ONE (1) HIP DUE TO INSTABILITY, AND ONE (1) HIP DUE TO OTHER-UNKNOWN CAUSES. BASED ON THE LEVEL OF DATA STRATIFICATION PROVIDED BY THE AOANJRR REGISTRY, THE REPORTED REASONS FOR REVISION CANNOT BE CONCLUSIVELY LINKED TO THE STEM MODEL NUMBERS LISTED IN EACH SPECIFIC LINE ITEM OF THE .CSV FILE ATTACHED TO THE SUMMARIZED 3500A SUBMISSION UNDER EXEMPTION RWD2300584, DUE TO THE REGISTRY¿S LIMITATION IN CORRELATING CLINICAL SYMPTOMS WITH INDIVIDUAL IMPLANT COMPONENTS. ALTOGETHER, A TOTAL QUANTITY OF AT LEAST FOUR HUNDRED AND SEVENTY-THREE (473) REVISIONS AND FORTY-FIVE (45) RE-REVISIONS HAVE BEEN REPORTED IN THE AOANJRR FOR THE REFLECTION ACETABULAR SHELL COMPONENTS, REDAPT SLEEVELESS REVISION STEMS, REFLECTION HA THREE-HOLE ACETABULAR SHELL COMPONENTS, AND REFLECTION 3-HOLE ACETABULAR SHELL COMPONENTS RESULTING IN A TOTAL OF 518 EVENTS SUMMARIZED THROUGH THIS 3500A FORM. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE REFLECTION ACETABULAR SYSTEM AND REDAPT SLEEVELESS MONOLITHIC FEMORAL SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR INDUSTRY REPORTS REVEALED THAT THE CUMULATIVE REVISION RATE FOR ALL REFLECTION ACETABULAR COMPONENTS USED IN PRIMARY THA WERE IN LINE WITH THE CLASS DEVICE ACROSS ALL AVAILABLE FOLLOW UP YEARS. THE CUMULATIVE RE-REVISION RATE FOR ALL REFPLECTION COMPONENTS USED DURING REVISION THA (16.0%) WERE IN LINE WITH THE CLASS (17.5%) AT 10 YEARS CONSIDERING THE OVERLAPPING CONFIDENCE INTERVALS. REGARDING THE AOANJRR INDUSTRY REPORT REVIEWED FOR THE REDAPT SLEEVELESS MONOLITHIC STEM IN PRIMARY THA, THE CUMULATIVE REVISION RATES ARE SIGNIFICANTLY HIGHER THAN THE CLASS AT 1 THROUGH 4 YEARS BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS. HOWEVER, WHEN ADJUSTED FOR AGE AND GENDER, THE HAZARD RATIO FOR REDAPT STEMS AFTER 1 MONTH FROM IMPLANTATION WAS NOT SIGNIFICANTLY DIFFERENT THAN THE CLASS DEVICE (P=0.622). THE OBSERVED DIFFERENCE IN CUMULATIVE REVISION RATES IS LIKELY DRIVEN BY IMPLANTATION OF REDAPT MONOLITHIC STEMS LARGELY FOR COMPLEX PRIMARY INDICATIONS, WHEN COMPARED TO THE CLASS. IN ADDITION, MOST REVISIONS OF REDAPT STEMS WERE FOR INFECTION (N=5), WHICH MAY BE RELATED TO THE SURGICAL ENVIRONMENT OR EXTERNAL CAUSES AND NOT DIRECTLY RELATED TO THE PROSTHESIS. FOR THE REDAPT SLEEVELESS MONOLITHIC STEM FOR REVISION THA ON THE AOANJRR REPORT, THE CUMULATIVE RE-REVISION RATE FOR THE REDAPT MONOLITHIC STEM IS IN LINE WITH THE CLASS THROUGH 5 YEARS, AS DEMONSTRATED BY OVERLAPPING CONFIDENCE INTERVALS. SPECIFIC ANALYSIS OF THE DEVICES IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Additional Manufacturer Narrative · 0

H11: THIS 3500A FORM IS BEING SUBMITTED AS A CORRECTION TO FOLLOW-UP REPORT 1020279-2025-01716, PREVIOUSLY SUBMITTED ON 15-OCT-2025. SPECIFICALLY, THE 'UDI NUMBER' FIELDS IN THE ATTACHED .CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE ITEM VERSION'). THESE UPDATES APPLY TO THE FOLLOWING COMPLAINTS AND REPLACE THE VALUES PREVIOUSLY PROVIDED: (B)(4). NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE .CSV FILE PREVIOUSLY SUBMITTED THROUGH FOLLOW-UP REPORT 1020279-2025-01716.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00279534-1-L1,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,54mm REFLECTION HA Three-Hole Acetabular Shell,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L2,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,54mm REFLECTION HA Three-Hole Acetabular Shell,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L3,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,56mm REFLECTION HA Three-Hole Acetabular Shell,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L4,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,58mm REFLECTION HA Three-Hole Acetabular Shell,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L5,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,58mm REFLECTION HA Three-Hole Acetabular Shell,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L6,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,62mm REFLECTION HA Three-Hole Acetabular Shell,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L7,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,62mm REFLECTION HA Three-Hole Acetabular Shell,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L8,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,62mm REFLECTION HA Three-Hole Acetabular Shell,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L9,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,62mm REFLECTION HA Three-Hole Acetabular Shell,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279534-1-L10,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,64mm REFLECTION HA Three-Hole Acetabular Shell,71336264,,71336264,,03596010454225,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION HA Three-Hole Acetabular Shell. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item.","Reporting Quarter: 2 (01-Apr-2025 to 30-Jun-2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of ninety-five (95) hips underwent revision THA procedures using a REFLECTION HA Three-Hole Acetabular Shell between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MEH, LPH, MBL. Of the eighteen (18) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for re-revision for all 18 re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: six (6) hips due to prothesis dislocation, five (5) due to infection, and the seven (7) remaining joints because of the following causes (one per joint): loosening, fracture, stem implant breakage, lysis, pain, heterotopic bone, and wear of the acetabular insert.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 18 re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION HA Three-Hole Acetabular Shell approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of ninety-five (95) hip joints experienced complications that were addressed with revision THA removal and replacement with REFLECTION Acetabular Shell implants in Australia, between 23-Oct-2000 and 24-Jul-2015. The mean cumulative revision rates for the REFLECTION Acetabular Shell were similar to the class during the first sixteen (16) years based on overlapping 95% confidence intervals. From this year onward, no data was collected for the REFLECTION Acetabular shell. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 3.2% (1.0%¿9.5%) vs 7.9% (7.4%¿8.4%) of the class.;-At 2nd postoperative year: 8.5% (4.4%¿16.3%) vs 10.2% (9.6%¿10.8%) of the class.;-At 3rd postoperative year: 11.8% (6.7%¿20.4%) vs 11.5% (10.9%¿12.2%) of the class.;-At 4th postoperative year: 13.0% (7.6%¿21.8%) vs 12.7% (12.1%¿13.4%) of the class.;-At 5th postoperative year: 13.0% (7.6%¿21.8%) vs 13.7% (13.0%¿14.4%) of the class.;-At 6th postoperative year: 13.0% (7.6%¿21.8%) vs 14.7% (14.0%¿15.4%) of the class.;-At 7th postoperative year: 13.0% (7.6%¿21.8%) vs 15.4% (14.6%¿16.2%) of the class.;-At 8th postoperative year: 13.0% (7.6%¿21.8%) vs 16.2% (15.4%¿17.0%) of the class.;-At 9th postoperative year: 16.0% (9.7%¿25.7%) vs 16.8% (16.0%¿17.7%) of the class.;-At 10th postoperative year: 16.0% (9.7%¿25.7%) vs 17.5% (16.7%¿18.4%) of the class.;-At 11th postoperative year: 17.8% (11.0%¿28.2%) vs 18.3% (17.4%¿19.2%) of the class.;-At 12th postoperative year: 17.8% (11.0%¿28.2%) vs 19.0% (18.1%¿20.0%) of the class.;-At 13th postoperative year: 20.0% (12.5%¿31.2%) vs 19.7% (18.7%¿20.9%) of the class.;-At 14th postoperative year: 20.0% (12.5%¿31.2%) vs 20.8% (19.6%¿22.2%) of the class.;-At 15th postoperative year: 20.0% (12.5%¿31.2%) vs 21.8% (20.4%¿23.4%) of the class.;-At 16th postoperative year: 23.5% (14.5%¿36.8%) vs 23.0% (21.3%¿24.8%) of the class.;;The hazard ratio for the REFLECTION Acetabular Shell vs. the class over the entire period is 1.00 (95% CI: 0.63¿1.59) with a p-value of 0.985. This indicates no statistically significant difference in the risk of second revision between the REFLECTION Acetabular Shell and other models when adjusted for age and gender.;Overall, eighteen (18) re-revisions occurred out of ninety-five (95) revision implantations, leading to a re-revision occurrence rate of 18.9%. The top reasons for re-revisions for all REFLECTION Shells were prosthesis dislocation (6 cases, 6.3%), and infection (5 cases, 5.3%). For all other reasons for re-revision no more than 1 case was recorded. Infection cases are not related to recurrent infections from primary surgeries, as cases with infection as indication for revision were excluded by the analysis from AOANJRR. Infection may arise due to multiple causes, which remain often unrelated to the implant. These may include inefficient sterilization of instruments during surgery or an infection at other body sites reaching the implant area.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L1,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L2,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L3,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L4,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L5,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L6,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L7,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L8,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L9,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279545-1-L10,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 64MM,71336264,,71336264,,03596010454225,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures between 23-Oct-2000 and 24-Jul-2015, using a REFLECTION 3-hole acetabular cup. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual cups reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of sixty-eight (68) hips underwent revision THA procedures using a REFLECTION 3-hole acetabular cup between 23-Oct-2000 and 24-Jul-2015. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the fifteen (15) re-revision surgeries reported for these implants, ten (10) re-revisions were associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of re-reasons for all fifteen (15) re-revision cases but does not distinguish which reasons are specifically linked to re-revision surgeries involving components approved under FDA product code MEH. The reported reasons for re-revision include: six (6) hips due to loosening, seven (7) hips due to prosthetic dislocation and two (2) hips due to other-unknown reasons.;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all fifteen (15) re-revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 10 re-revisions associated with hips that had previously received a REFLECTION 3-hole acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for re-revision exclusively to the subset of 10 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of sixty-eight (68) revision THA procedures with REFLECTION 3-hole acetabular cups have been performed in Australia between 23-Oct-2000 and 24-Jul-2015. The cumulative re-revision rates for the REFLECTION 3-hole cups were in line with the AOANJRR Revision THA class across all available follow up years. REFLECTION 3-hole cups cumulative re-revision incidence rates showed large confidence intervals, at least in part due to the low number of implantations followed-up. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.5% (0.2%-10.0%) vs 7.9% (7.3%-8.4%) of the class.;¿ At 2nd postoperative year: 8.9% (4.1%-18.7%) vs 10.2% (9.6%-10.8%) of the class.;¿ At 3rd postoperative year: 13.5% (7.3%-24.4%) vs 11.5% (10.9%-12.2%) of the class.;¿ At 5th postoperative year: 15.2% (8.5%-26.5%) vs 13.6% (13.0%-14.4%) of the class.;¿ At 10th postoperative year: 19.8% (11.6%-32.6%) vs 17.5% (16.6%-18.4%) of the class.;¿ At 15th postoperative year: 22.9% (13.6%-37.0%) vs 21.8% (20.4%-23.3%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L1,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 46MM,71334246,,71334246,,03596010452771,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L2,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 48MM,71334248,,71334248,,03596010452788,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L3,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 48MM,71334248,,71334248,,03596010452788,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L4,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 48MM,71334248,,71334248,,03596010452788,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L5,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L6,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L7,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L8,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L9,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L10,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L11,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L12,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L13,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L14,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L15,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L16,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L17,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L18,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L19,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L20,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L21,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L22,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SZ 50MM,71334250,,71334250,,03596010452795,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L23,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L24,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L25,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L26,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L27,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L28,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L29,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L30,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L31,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L32,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L33,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L34,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L35,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L36,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L37,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 52MM,71334252,,71334252,,03596010452801,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L38,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L39,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L40,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L41,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L42,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L43,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L44,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L45,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L46,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L47,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L48,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L49,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L50,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L51,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L52,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L53,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 54MM,71334254,,71334254,,03596010452818,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L54,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L55,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L56,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L57,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L58,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L59,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L60,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L61,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L62,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L63,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L64,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L65,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L66,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L67,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L68,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L69,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L70,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L71,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L72,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L73,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 56MM,71334256,,71334256,,03596010452825,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L74,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L75,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L76,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L77,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L78,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L79,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L80,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L81,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L82,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L83,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L84,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L85,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L86,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L87,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L88,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L89,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L90,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L91,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L92,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L93,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L94,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L95,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 58MM,71334258,,71334258,,03596010452832,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L96,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 60MM,71334260,,71334260,,03596010452849,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L97,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 60MM,71334260,,71334260,,03596010452849,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L98,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 60MM,71334260,,71334260,,03596010452849,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L99,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 60MM,71334260,,71334260,,03596010452849,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L100,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 62MM,71334262,,71334262,,03596010452856,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L101,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 62MM,71334262,,71334262,,03596010452856,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L102,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 62MM,71334262,,71334262,,03596010452856,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L103,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION NO HOLE HA ACETABULAR SHELL SIZE 62MM,71334262,,71334262,,03596010452856,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L104,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION ACETABULAR SHELL MULTI-HOLE SIZE 50MM SIZE E,71335150,,71335150,,03596010000781,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L105,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 46MM,71336246,,71336246,,03596010452696,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L106,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 46MM,71336246,,71336246,,03596010452696,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L107,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 46MM,71336246,,71336246,,03596010452696,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L108,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 46MM,71336246,,71336246,,03596010452696,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L109,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L110,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L111,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L112,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L113,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L114,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L115,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L116,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L117,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L118,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L119,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 48MM,71336248,,71336248,,03596010452702,K211176,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L120,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L121,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L122,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L123,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L124,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L125,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L126,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L127,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L128,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L129,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L130,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L131,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L132,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L133,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L134,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L135,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L136,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L137,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L138,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L139,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L140,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L141,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L142,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L143,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L144,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L145,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L146,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L147,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L148,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L149,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L150,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L151,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L152,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L153,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L154,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L155,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L156,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 50MM,71336250,,71336250,,03596010452719,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L157,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L158,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L159,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L160,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L161,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L162,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L163,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L164,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L165,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L166,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L167,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L168,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L169,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L170,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L171,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L172,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L173,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L174,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L175,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L176,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L177,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L178,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L179,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L180,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L181,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L182,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L183,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L184,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L185,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L186,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L187,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L188,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L189,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L190,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L191,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L192,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L193,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L194,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L195,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L196,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L197,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L198,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L199,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L200,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L201,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L202,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L203,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L204,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L205,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L206,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L207,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L208,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L209,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 52MM,71336252,,71336252,,03596010452726,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L210,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L211,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L212,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L213,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L214,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L215,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L216,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L217,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L218,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L219,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L220,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L221,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L222,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L223,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L224,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L225,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L226,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L227,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L228,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L229,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L230,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L231,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L232,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L233,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L234,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L235,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L236,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L237,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L238,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L239,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L240,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L241,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L242,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L243,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L244,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L245,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L246,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L247,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L248,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L249,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L250,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L251,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L252,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L253,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L254,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L255,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L256,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L257,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L258,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L259,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L260,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L261,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L262,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L263,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L264,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L265,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L266,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L267,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L268,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L269,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L270,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L271,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L272,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L273,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L274,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L275,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L276,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L277,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L278,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L279,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L280,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L281,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L282,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L283,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L284,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L285,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L286,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L287,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L288,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L289,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L290,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L291,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L292,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L293,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L294,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L295,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L296,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L297,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L298,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L299,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L300,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L301,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 54MM,71336254,,71336254,,03596010452733,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L302,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L303,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L304,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L305,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L306,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L307,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L308,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L309,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L310,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L311,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L312,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L313,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L314,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L315,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L316,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L317,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L318,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L319,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L320,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L321,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L322,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L323,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L324,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L325,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L326,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L327,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L328,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L329,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L330,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L331,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L332,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L333,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L334,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L335,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L336,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L337,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L338,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L339,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L340,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L341,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L342,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L343,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L344,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L345,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L346,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L347,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L348,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L349,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L350,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L351,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L352,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L353,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L354,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L355,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L356,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L357,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L358,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L359,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L360,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L361,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L362,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 56MM,71336256,,71336256,,03596010452740,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L363,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L364,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L365,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L366,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L367,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L368,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L369,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L370,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L371,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L372,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L373,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L374,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L375,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L376,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L377,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L378,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L379,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L380,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L381,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L382,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L383,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L384,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L385,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L386,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L387,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L388,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L389,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L390,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L391,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L392,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L393,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L394,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L395,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L396,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L397,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L398,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L399,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L400,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L401,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L402,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L403,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L404,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L405,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L406,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L407,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L408,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L409,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L410,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L411,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L412,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L413,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L414,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L415,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L416,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L417,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L418,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 58MM,71336258,,71336258,,03596010452757,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L419,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L420,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L421,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L422,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L423,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L424,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L425,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L426,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L427,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L428,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L429,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L430,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L431,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L432,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L433,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L434,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L435,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L436,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L437,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L438,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L439,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L440,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L441,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L442,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L443,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L444,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L445,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L446,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L447,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L448,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L449,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L450,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L451,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L452,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 60MM,71336260,,71336260,,03596010452764,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L453,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L454,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L455,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L456,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L457,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L458,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L459,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L460,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L461,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L462,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L463,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L464,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 62MM,71336262,,71336262,,03596010454218,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00279561-1-L465,,10/15/2025,6/2/2025,REFLECTION Acetabular Cup System,REFLECTION HA THREE HOLE SHELL SIZE 64MM,71336264,,71336264,,03596010454225,K990666,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures between 02-Sep-1999 and 28-Jan-2025, using a REFLECTION Acetabular cup. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual cup reported through this line item.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) from Australia, a total of fifteen thousand four hundred and fifty-six (15,456) hips underwent primary THA procedures using a REFLECTION Acetabular cup between 02-Sep-1999 and 28-Jan-2025. This total includes cups approved for use in the United States under FDA product codes MBL and MEH. Of the eight hundred forty-two (842) revision surgeries reported for these implants, four hundred seventy-five (465) revisions were associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH.;The AOANJRR report provides the complete list of reasons for revision for all 842 revision cases but does not distinguish which reasons are specifically linked to revision surgeries involving components approved under FDA product code MEH. The reported reasons for revision include: one hundred and forty-four (144) hips due to fracture, two hundred and forty (240) hips due to loosening, one hundred and thirty-four (134) hips due to infection, one hundred and sixty-three (163) hips due to prosthesis dislocation, sixty-eight (68) hips due to lysis, nine (9) hips due to pain, seven (7) hips due to instability, six (6) hips due to leg length discrepancy, six (6) hips due to malposition, five (5) hips due to implant breakage ¿ stem, four (4) hips due to metal related pathology, one (1) hip due to implant breakage ¿ acetabular insert, forty-three (43) hips due to wear ¿ acetabular insert, two (2) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, one (1) hip due to tumour, one (1) hip due to heterotopic bone, one (1) hip due to wear ¿ acetabulum and four (4) hips due to other-unspecified reasons. ;In consideration of the above, the analysis conducted on the AOANJRR registry report encompasses all 842 revision surgeries reported for this product family. However, the .csv file submitted under the requirements of RWD2300584 includes only 465 revisions associated with hips that had previously received a REFLECTION Acetabular cup approved under FDA product code MEH. Due to the structure of AOANJRR report, it is not possible to isolate or attribute specific statistical outcomes or reasons for revision exclusively to the subset of 465 cases. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of fifteen thousand four hundred and fifty-six (15,456) primary THA procedures with REFLECTION Acetabular cups were performed in Australia between 02-Sep-1999 and 28-Jan-2025. When compared to all other THA reported in the AOANJRR, REFLECTION Shells performed better across all available follow-up years based on the cumulative percent revision. The following cumulative revision rates with 95% confidence intervals are presented in this report:; ;¿ At 1st postoperative year: 1.3% (1.1%¿1.5%) vs 1.7% (1.7%¿1.8%) of the class.;¿ At 2nd postoperative year: 1.7% (1.5%¿1.9%) vs 2.2% (2.2%¿2.2%) of the class.;¿ At 3rd postoperative year: 1.9% (1.7%¿2.2%) vs 2.6% (2.5%¿2.6%) of the class.;¿ At 4th postoperative year: 2.2% (2.0%¿2.4%) vs 2.9% (2.8%¿2.9%) of the class.;¿ At 5th postoperative year: 2.4% (2.2%¿2.6%) vs 3.2% (3.1%¿3.2%) of the class.;¿ At 6th postoperative year: 2.7% (2.4%¿3.0%) vs 3.5% (3.4%¿3.5%) of the class.;¿ At 7th postoperative year: 2.9% (2.7%¿3.2%) vs 3.8% (3.7%¿3.8%) of the class.;¿ At 8th postoperative year: 3.2% (3.0%¿3.5%) vs 4.1% (4.0%¿4.1%) of the class.;¿ At 9th postoperative year: 3.7% (3.4%¿4.0%) vs 4.4% (4.4%¿4.5%) of the class.;¿ At 10th postoperative year: 4.0% (3.7%¿4.4%) vs 4.8% (4.7%¿4.8%) of the class.;¿ At 11th postoperative year: 4.4% (4.1%¿4.8%) vs 5.1% (5.1%¿5.2%) of the class.;¿ At 12th postoperative year: 4.9% (4.6%¿5.3%) vs 5.6% (5.5%¿5.6%) of the class.;¿ At 13th postoperative year: 5.4% (5.0%¿5.8%) vs 6.0% (5.9%¿6.1%) of the class.;¿ At 14th postoperative year: 5.8% (5.4%¿6.2%) vs 6.4% (6.3%¿6.5%) of the class.;¿ At 15th postoperative year: 6.2% (5.8%¿6.7%) vs 6.9% (6.8%¿7.0%) of the class.;¿ At 16th postoperative year: 6.7% (6.2%¿7.2%) vs 7.4% (7.3%¿7.5%) of the class.;¿ At 17th postoperative year: 7.2% (6.7%¿7.7%) vs 7.9% (7.7%¿8.0%) of the class.;¿ At 18th postoperative year: 7.6% (7.0%¿8.2%) vs 8.3% (8.2%¿8.5%) of the class.;¿ At 19th postoperative year: 8.2% (7.6%¿8.8%) vs 8.8% (8.7%¿9.0%) of the class.;¿ At 20th postoperative year: 8.5% (7.9%¿9.2%) vs 9.4% (9.2%¿9.6%) of the class.;¿ At 21st postoperative year: 9.3% (8.5%¿10.2%) vs 9.9% (9.7%¿10.1%) of the class.;¿ At 22nd postoperative year: 10.3% (9.3%¿11.4%) vs 10.4% (10.2%¿10.6%) of the class.;¿ At 23rd postoperative year: 10.3% (9.3%¿11.4%) vs 10.8% (10.6%¿11.1%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. These liners have been phased out and are no longer marketed. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.;",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L1,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354463,,71354463,,00885556580578,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L2,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354467,,71354467,,00885556580615,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L3,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354467,,71354467,,00885556580615,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L4,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 21 STANDARD OFFSET,71354471,,71354471,,00885556580646,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L5,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354703,,71354703,,00885556579282,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L6,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 STANDARD OFFSET,71354706,,71354706,,00885556579312,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L7,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354707,,71354707,,00885556579329,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283492-1-L8,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 HIGH OFFSET,71354724,,71354724,,00885556579466,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Stem. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025) ;;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and thirty-one (131) hips underwent primary THA procedures between 22-Jul-2018 and 8-Apr-2025, using REDAPT Sleeveless Revision Stem. From these, eight (8) hips were later revised due to the following complications: five (5) hips due to infection, one (1) hip due to prosthesis dislocation, one (1) hip due to fracture, and one (1) hip due to malposition. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 22-Jul-2018 and 8-Apr-2025 in Australia. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and thirty-one (131) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 22-Jul-2018 and 8-Apr-2025. ;;The cumulative revision rates for the REDAPT Sleeveless Revision Stem are higher than the class at 1 through 4 years based on non-overlapping confidence intervals. ;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;-At 1st postoperative year: 6.1% (3.1%-11.9%) vs 1.8% (1.7%-1.8%) of the class. ;;-At 2nd postoperative year: 6.1% (3.1%-11.9%) vs 2.2% (2.2%-2.2%) of the class. ;;-At 3rd postoperative year: 6.1% (3.1%-11.9%) vs 2.6% (2.5%-2.6%) of the class. ;;-At 4th postoperative year: 6.1% (3.1%-11.9%) vs 2.9% (2.8%-2.9%) of the class. ;;The observed difference in cumulative revision rates is likely driven by implantation of REDAPT Sleeveless Revision Stems largely for complex primary indications, when compared to the class. Also, the most common reason for revision was for infection (N=5; 3.8%), which may be related to the surgical environment or external causes and not directly related to the prosthesis. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded. ",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L1,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 17 STANDARD OFFSET,71354466,,71354466,,00885556580608,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L2,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 17 STANDARD OFFSET,71354466,,71354466,,00885556580608,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L3,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354467,,71354467,,00885556580615,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L4,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 19 STANDARD OFFSET,71354468,,71354468,,00885556580622,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L5,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 190MM SLEEVELESS REVISION STEM SIZE 19 STANDARD OFFSET,71354468,,71354468,,00885556580622,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L6,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 13 STANDARD OFFSET,71354702,,71354702,,00885556579169,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L7,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 14 STANDARD OFFSET,71354703,,71354703,,00885556579282,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L8,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 15 STANDARD OFFSET,71354704,,71354704,,00885556579299,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L9,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 15 STANDARD OFFSET,71354704,,71354704,,00885556579299,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L10,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 16 STANDARD OFFSET,71354705,,71354705,,00885556579305,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L11,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 16 STANDARD OFFSET,71354705,,71354705,,00885556579305,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L12,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 22 STANDARD OFFSET,71354712,,71354712,,00885556579367,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L13,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 13 HIGH OFFSET,71354719,,71354719,,00885556579435,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L14,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 14 HIGH OFFSET,71354721,,71354721,,00885556579893,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L15,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 15 HIGH OFFSET,71354722,,71354722,,00885556579442,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L16,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 HIGH OFFSET,71354724,,71354724,,00885556579466,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L17,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 17 HIGH OFFSET,71354724,,71354724,,00885556579466,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L18,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 240MM SLEEVELESS REVISION STEM SIZE 20 HIGH OFFSET,71354727,,71354727,,00885556579497,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L19,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 15 STANDARD OFFSET,71354739,,71354739,,00885556579602,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L20,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 16 STANDARD OFFSET,71354741,,71354741,,00885556579619,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L21,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 18 STANDARD OFFSET,71354743,,71354743,,00885556579633,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L22,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 20 STANDARD OFFSET,71354745,,71354745,,00885556579657,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L23,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 15 HIGH OFFSET,71354757,,71354757,,00885556579763,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L24,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 16 HIGH OFFSET,71354758,,71354758,,00885556579770,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00283498-1-L25,,10/15/2025,7/30/2025,REDAPT Sleeveless Monolithic Femoral System ,REDAPT 300MM SLEEVELESS REVISION STEM SIZE 22 HIGH OFFSET,71354765,,71354765,,00885556579831,K151902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, one (1) hip was later re-revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for re-revision can be definitively linked to the individual stem reported through this line item.","Reporting Quarter: 3 (July 1 ¿ September 30, 2025);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of three hundred and forty-five (345) hips underwent revision THA procedures between 24-Aug-2018 and 31-May-2025, using REDAPT Sleeveless Revision Stem. From these, twenty-five (25) hips were later re-revised due to the following complications: ten (10) hips due to infection, five (5) hips due to loosening, four (4) hips due to prosthesis dislocation, four (4) hips due to fracture, one (1) hip due to instability, and one (1) hip due to other-unknown causes. Based on the level of data stratification provided by the AOANJRR registry, the reported reasons for revision cannot be conclusively linked to the stem model numbers listed in each specific line item of the .csv file attached to the summarized 3500A submission under exemption RWD2300584, due to the registry¿s limitation in correlating clinical symptoms with individual implant components.;;Timeframe of Registry data: Implantations conducted between 24-Aug-2018 and 31-May-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Sleeveless Stem presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred and forty-five (345) procedures with REDAPT Sleeveless Revision Stem have been performed in Australia between 24-Aug-2018 and 31-May-2025. ;;The cumulative re-revision rate for the REDAPT Sleeveless Revision Stem is in line with the class through 5 years, as demonstrated by overlapping confidence intervals. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;¿ At 1st postoperative year: 5.7% (3.7%-8.8%) vs 7.4% (7.0%-7.9%) of the class.;¿ At 2nd postoperative year: 7.8% (5.2%-11.4%) vs 9.5% (9.0%-10.1%) of the class.;¿ At 3rd postoperative year: 8.4% (5.7%-12.3%) vs 11.1% (10.6%-11.7%) of the class.;¿ At 4th postoperative year: 8.4% (5.7%-12.3%) vs 12.3% (11.7%-12.9%) of the class.;¿ At 5th postoperative year: 8.4% (5.7%-12.3%) vs 13.3% (12.7%-13.9%) of the class.;;A total of 25 re-revisions for REDAPT stems used in revision THA were reported by the AOANJRR. The most common reason for re-revision was infection (N=10; 2.9%) followed by loosening (N=5; 1.4%). ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,1;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIAN ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY AND REVISION JOINT REPLACEMENT PROCEDURES: 1. PRIMARY THA PROCEDURES: REFLECTION ACETABULAR SHELL COMPONENTS: IMPLANTED IN FIFTEEN THOUSAND FOUR HUNDRED AND FIFTY-SIX (15,456) HIPS BETWEEN 02-SEP-1999 AND 28-JAN-2025. THIS TOTAL INCLUDES CUPS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES MBL AND MEH. OF THE EIGHT HUNDRED FORTY-TWO (842) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, FOUR HUNDRED SEVENTY-FIVE (465) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 842 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MEH. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, NINE (9) HIPS DUE TO PAIN, SEVEN (7) HIPS DUE TO INSTABILITY, SIX (6) HIPS DUE TO LEG LENGTH DISCREPANCY, SIX (6) HIPS DUE TO MALPOSITION, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, FOUR (4) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, ONE (1) HIP DUE TO WEAR ¿ ACETABULUM AND FOUR (4) HIPS DUE TO OTHER-UNSPECIFIED REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 842 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 465 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 465 CASES. REDAPT SLEEVELESS REVISION STEMS: IMPLANTED IN ONE HUNDRED AND THIRTY-ONE (131) HIPS BETWEEN 22-JUL-2018 AND 8-APR-2025.FROM THESE, EIGHT (8) HIPS WERE LATER REVISED DUE TO THE FOLLOWING COMPLICATIONS: FIVE (5) HIPS DUE TO INFECTION, ONE (1) HIP DUE TO PROSTHESIS DISLOCATION, ONE (1) HIP DUE TO FRACTURE, AND ONE (1) HIP DUE TO MALPOSITION. BASED ON THE LEVEL OF DATA STRATIFICATION PROVIDED BY THE AOANJRR REGISTRY, THE REPORTED REASONS FOR REVISION CANNOT BE CONCLUSIVELY LINKED TO THE STEM MODEL NUMBERS LISTED IN EACH SPECIFIC LINE ITEM OF THE .CSV FILE ATTACHED TO THE SUMMARIZED 3500A SUBMISSION UNDER EXEMPTION RWD2300584, DUE TO THE REGISTRY¿S LIMITATION IN CORRELATING CLINICAL SYMPTOMS WITH INDIVIDUAL IMPLANT COMPONENTS. 2. REVISION THA PROCEDURES: - REFLECTION HA THREE-HOLE ACETABULAR SHELL COMPONENTS: IMPLANTED IN NINETY-FIVE (95) HIPS BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES CUPS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES MEH, LPH, MBL. OF THE EIGHTEEN (18) RE-REVISION SURGERIES REPORTED FOR THESE IMPLANTS, TEN (10) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION HA THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MEH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR RE-REVISION FOR ALL 18 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MEH. THE REPORTED REASONS FOR REVISION INCLUDE: SIX (6) HIPS DUE TO PROTHESIS DISLOCATION, FIVE (5) DUE TO INFECTION, AND THE SEVEN (7) REMAINING JOINTS BECAUSE OF THE FOLLOWING CAUSES (ONE PER JOINT): LOOSENING, FRACTURE, STEM IMPLANT BREAKAGE, LYSIS, PAIN, HETEROTOPIC BONE, AND WEAR OF THE ACETABULAR INSERT. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 18 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 10 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION HA THREE-HOLE ACETABULAR SHELL APPROVED UNDER FDA PRODUCT CODE MEH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 10 CASES. REFLECTION 3-HOLE ACETABULAR SHELL COMPONENTS: IMPLANTED IN SIXTY-EIGHT (68) HIPS BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES CUPS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES MBL AND MEH. OF THE FIFTEEN (15) RE-REVISION SURGERIES REPORTED FOR THESE IMPLANTS, TEN (10) RE-REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION 3-HOLE ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF RE-REASONS FOR ALL FIFTEEN (15) RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE MEH. THE REPORTED REASONS FOR RE-REVISION INCLUDE: SIX (6) HIPS DUE TO LOOSENING, SEVEN (7) HIPS DUE TO PROSTHETIC DISLOCATION AND TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL FIFTEEN (15) RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 10 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION 3-HOLE ACETABULAR CUP APPROVED UNDER FDA PRODUCT CODE MEH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 10 CASES. REDAPT SLEEVELESS REVISION STEMS: IMPLANTED IN THREE HUNDRED AND FORTY-FIVE (345) HIPS BETWEEN 24-AUG-2018 AND 31-MAY-2025. FROM THESE, TWENTY-FIVE (25) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TEN (10) HIPS DUE TO INFECTION, FIVE (5) HIPS DUE TO LOOSENING, FOUR (4) HIPS DUE TO PROSTHESIS DISLOCATION, FOUR (4) HIPS DUE TO FRACTURE, ONE (1) HIP DUE TO INSTABILITY, AND ONE (1) HIP DUE TO OTHER-UNKNOWN CAUSES. BASED ON THE LEVEL OF DATA STRATIFICATION PROVIDED BY THE AOANJRR REGISTRY, THE REPORTED REASONS FOR REVISION CANNOT BE CONCLUSIVELY LINKED TO THE STEM MODEL NUMBERS LISTED IN EACH SPECIFIC LINE ITEM OF THE .CSV FILE ATTACHED TO THE SUMMARIZED 3500A SUBMISSION UNDER EXEMPTION RWD2300584, DUE TO THE REGISTRY¿S LIMITATION IN CORRELATING CLINICAL SYMPTOMS WITH INDIVIDUAL IMPLANT COMPONENTS. ALTOGETHER, A TOTAL QUANTITY OF AT LEAST FOUR HUNDRED AND SEVENTY-THREE (473) REVISIONS AND FORTY-FIVE (45) RE-REVISIONS HAVE BEEN REPORTED IN THE AOANJRR FOR THE REFLECTION ACETABULAR SHELL COMPONENTS, REDAPT SLEEVELESS REVISION STEMS, REFLECTION HA THREE-HOLE ACETABULAR SHELL COMPONENTS, AND REFLECTION 3-HOLE ACETABULAR SHELL COMPONENTS RESULTING IN A TOTAL OF 518 EVENTS SUMMARIZED THROUGH THIS 3500A FORM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2288462		PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU	MEH	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR	Unknown

Terms

Patient problem · 17

• Arthralgia
• Aseptic loosening
• Deformity/ Disfigurement
• Extraskeletal ossification
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Medical device site infection
• Metal Related Pathology
• Necrosis
• Osteolysis
• Pain
• Periprosthetic fracture
• Solid Tumour
• Synovitis
• Unequal Limb Length
• Unspecified Infection

Product problems · 8

• Adverse Event Without Identified Device or Use Problem
• Fracture
• Improper or Incorrect Procedure or Method
• Malposition of Device
• Material Erosion
• Migration
• Naturally Worn
• Osseointegration Problem

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission